510(k) K040837

MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE by Medicel AG — Product Code MSS

K040837 is an FDA 510(k) premarket notification submitted by Medicel AG for the device "MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE". The FDA issued a decision of Substantially Equivalent on June 17, 2004. The device falls under product code MSS (Folders And Injectors, Intraocular Lens (Iol)), a Class I device regulated under 21 CFR 886.4300. Medicel AG has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2004
Date Received
March 31, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Folders And Injectors, Intraocular Lens (Iol)
Device Class
Class I
Regulation Number
886.4300
Review Panel
OP
Submission Type